Product Classification

• Device: changer, radiographic film/cassette
• Regulation Description: Radiographic film/cassette changer.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: KPX
• Submission Type: Enforcement Discretion
• Regulation Number: 892.1860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 4090:2001 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.